Beacon Hill Medical Pharmacy Recalls Calcium EDTA Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Calcium EDTA 300 mg/mL Injectable because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant risks such as sterility assurance failures in injectable products are categorized as Severe.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C. is recalling all configurations of Calcium EDTA 300 mg/mL Injectable. The product is sterile, prescription-only, and intended for intravenous and subcutaneous use only. It was compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, in Southfield, Michigan, and distributed nationwide in the United States.
The recall was initiated due to a lack of assurance of sterility. FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance. The specific lot codes identified in the recall are 01082013@7 and 05062013@29.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions on disposal or replacement.
The recalled product
- Product
- CALCIUM EDTA 300 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
- Manufacturer
- Beacon Hill Medical Pharmacy, P.C.
- Category
- Drug — Injectable
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 01082013@7 and 05062013@29
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 86 recalled by Beacon Hill Medical Pharmacy, P.C. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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